LIraglutide and Beta-cell RepAir (LIBRA) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01270789
First received: January 4, 2011
Last updated: August 15, 2013
Last verified: July 2013
  Purpose

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). We propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM. This study may demonstrate an important beta-cell protective capacity of liraglutide.


Condition Intervention Phase
Type 2 Diabetes
Drug: Liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Assessing the Effect of Liraglutide on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes Mellitus: The LIraglutide and Beta-cell RepAir (LIBRA) Study

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2) [ Time Frame: 48-weeks ] [ Designated as safety issue: No ]
    ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index.


Secondary Outcome Measures:
  • Glycemic Control [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    • A1c
    • Fasting glucose, 2 hour glucose, and AUCgluc on OGTT
    • Proportion of participants with A1c <7% at study end
    • Glucose tolerance status at study end (NGT, pre-diabetes, diabetes)
    • Proportion of participants with fasting glucose in non-diabetic range at study end (ie. <7.0 mmol/L)
    • Time to loss of glycemic control


Enrollment: 63
Study Start Date: January 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide Drug: Liraglutide
Liraglutide administered as once daily sc injection
Other Name: Victoza
Placebo Comparator: Placebo Drug: placebo
placebo administered as once daily sc injection

Detailed Description:

In this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up. The hypothesis under study is whether liraglutide can preserve beta-cell function.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women between the ages of 30 and 75 years inclusive
  • physician-diagnosed type 2 diabetes of </= 7 years duration
  • negative for anti-GAD antibodies
  • on 0-2 oral anti-diabetic medications
  • A1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications

Exclusion Criteria:

  • use of insulin, GLP-1 agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitor
  • type 1 diabetes or secondary forms of diabetes
  • major illness with life expectancy < 5 years
  • involvement in another study requiring drug therapy
  • hypersensitivity to insulin, liraglutide, or metformin
  • renal dysfunction
  • hepatic dysfunction
  • history of pancreatitis
  • family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma
  • personal history of non-familial medullary thyroid carcinoma
  • malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
  • excessive alcohol consumption
  • unwillingness to undergo multiple daily insulin injection therapy
  • unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy
  • congestive heart failure
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270789

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Novo Nordisk A/S
Investigators
Principal Investigator: Ravi Retnakaran, MD Mount Sinai Hospital, Toronto
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01270789     History of Changes
Other Study ID Numbers: 10-0230-A
Study First Received: January 4, 2011
Last Updated: August 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
beta-cell function
GLP-1 analogue
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014